---
title: "HardyCHROM CRE, selective and differential culture medium for antimicrobial s... — FDA record Z-2041-2025 | Is It on Recall"
description: "Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae."
url: https://isitonrecall.com/recall/fda-device-z-2041-2025-hardychrom-cre-selective-and-differential-culture-medium-for-antimicrobial-susceptibility-testing-pr/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog N... — FDA record Z-2041-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 6, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: HardyCHROM CRE, selective and differential culture medium for antimicrobial susceptibility testing, Product Catalog No. G323
- **Reason**: Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Klebsiella pneumoniae.
- **Classification**: Class II
- **Recalling firm**: Hardy Diagnostics
- **Quantity**: 4300 ea
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-2041-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2041-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI 008165760257704 G323 lot 653594P: Manufactured on March 6, 2025; Expires on May 15, 2025 G323 lot 655101P: Manufactured on April 4, 2025; Expires on June 13, 2025 G323 lot 656816P: Manufactured on April 16, 2025; Expires on June 25, 2025 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

US domestic distribution to the following states: AZ, CA, CO, FL, GA, IL, MD, ME, MI, MN, MO, NC, NE, NV, NY, PA, PR, TX, UT, VA, WI and WV.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [Arizona](https://isitonrecall.com/state/arizona/)
- [California](https://isitonrecall.com/state/california/)
- [Colorado](https://isitonrecall.com/state/colorado/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Georgia](https://isitonrecall.com/state/georgia/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Maryland](https://isitonrecall.com/state/maryland/)
- [Maine](https://isitonrecall.com/state/maine/)
- [Michigan](https://isitonrecall.com/state/michigan/)
- [Minnesota](https://isitonrecall.com/state/minnesota/)
- [Missouri](https://isitonrecall.com/state/missouri/)
- [North Carolina](https://isitonrecall.com/state/north-carolina/)
- [Nebraska](https://isitonrecall.com/state/nebraska/)
- [Nevada](https://isitonrecall.com/state/nevada/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Pennsylvania](https://isitonrecall.com/state/pennsylvania/)
- [Texas](https://isitonrecall.com/state/texas/)
- [Utah](https://isitonrecall.com/state/utah/)
- [Virginia](https://isitonrecall.com/state/virginia/)
- [Wisconsin](https://isitonrecall.com/state/wisconsin/)
- [West Virginia](https://isitonrecall.com/state/west-virginia/)

## Dates in the source

- **Report date**: Jul 9, 2025
- **Recall initiation date**: May 6, 2025
- **Center classification date**: Jun 27, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2041-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [Hardy Diagnostics records](https://isitonrecall.com/brand/hardy-diagnostics/)